Alzheimer's DiseasePhase 1NCT01702480
Effects of Triglycerides on Age-Related Cognitive Function Decline in Older Subjects
A Phase 1 study testing GSK2981710 in people with Alzheimer's Disease, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK] Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study investigating the PK profile of four different doses of GSK2981710. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- GSK2981710
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2012to 3 Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female individuals between the ages of 55 years and 80 years inclusive.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. Child-bearing potential and has a negative pregnancy test on each of the testing visits.
- Body weight >=50 kilogram (kg) in males and >=40 kg in females. Body mass index (BMI) in the range 18.0 to 29.9 kg/meter (m)^2.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Sufficiently fluent in English that they are able to understand written and spoken instructions in the opinion of the investigator.
- Supine blood pressure between 110/70 to 150/90 millimetres of mercury (mmHg) inclusive at screening. Patients with a current history of hypertension who are controlled on a stable regimen for at least 3 months prior to the study and are asymptomatic can be included.
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- 12 lead electrocardiogram (ECG) without any clinically significant abnormality as judged by the Investigator, and QT interval corrected using Bazett's formula (QTcB) or QT interval corrected using Fridericia's formula (QTcF) <=450 millisecond (msec)
- Suitable for cannulation and with adequate venous access
- Aspartate aminotransferase (AST), Alanine transaminase (ALT), alkaline phosphatase and bilirubin <= 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- For Part 2: Performs below the cut-off level on the Wechsler logical memory test below the mean level of performance of young, healthy adults.
- For Part 2: Otherwise normal neuropsychological performance as indicated by performance above the required level on the MINI Mental State Examination (MMSE) (a score of 27 or above is eligible).
Who cannot join
- Previous or current medical condition, which as judged by the Investigator with consultation with the GSK Medical Monitor if required, may compromise subject safety or may interfere with the study procedures or the interpretation of data..
- Learning disability or learning disorder.
- Current history of Axis I psychiatric disorder as determined by MINI interview
- A drug dependence by the Diagnostic and Statistical Manual of Mental Disorders, Fourth (DSM-IV) criteria within the last 6 months as assessed by the Mini-international neuropsychiatric interview (MINI).
- A fall of at least 20 mm Hg systolic blood pressure within three minutes of standing upright at screening
- A positive pre-study human immunodeficiency virus (HIV), Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
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- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of alcohol or substance abuse or dependence in the 6 months prior to screening as determined by the investigator. Abuse of alcohol, defined for males, as an average weekly intake of greater than 21 units (or an average daily intake of greater than 3 units), or defined for females, as an average weekly intake of greater than 14 units (or an average daily intake of greater than 2 units). One unit is equivalent to a half-pint (220 milliliters [mL]) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
- Current smokers defined as regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Positive urine drug or alcohol breath test at screening or when tested at any of the study visits.
- Lactating females or pregnant females as determined by a positive urine/serum human chorionic gonadotropin (hCG) test at screening or when tested at any of the study visits.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the testing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Lactose intolerant or allergic to milk or soy products
- The subject is on a diet including any diet that restricts or modifies intake of a particular type of food, e.g. carbohydrates, proteins, fats, or is on a ketogenic diet.
- Fasting Triglycerides equal to or more than 4.5 millimoles per litre; (mmol/L) at screening
- Subject who, in the investigator/designee's judgement, poses a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any evidence of suicidal ideation on any questionnaires e.g. type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) in the last 6 months.
- History of sensitivity or allergy to drug or components thereof, or other allergy, that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 2GG
About this study
Official title: Effects of Medium-Chain Triglycerides on Cognitive Function in Older Subjects With Age-Related Cognitive Decline
This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK] Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study investigating the PK profile of four different doses of GSK2981710. Eight subjects will receive a single dose of GSK2981710 10 gram (g), 20 g, 30 g, 40 g or placebo in the morning and have PK assessments (every 0.5 hrs up to 8 hrs post-dose) throughout the day in each period. Each subject will complete a total of four dosing sessions and 4 days of PK assessments in 2 weeks. The Part 1 PK data will be used for dose selection and pharmacodynamic (PD) assessment period in Part 2. If the data from Part 1 is inconclusive, an additional 8 subjects may be recruited and Part 1 repeated (possibly dropping some doses) to increase confidence. A subject's total participation in Part 1 of the study will last a maximum of approximately 7 weeks including screening. Subjects who have completed Part 1 may be screened for eligibility and enrolled for Part 2.
Part 2 (PD Assessment) is a double blind randomized, placebo-controlled 2-period crossover design with 14-day treatment periods investigating the efficacy (cognitive performance) and tolerability (gastrointestinal [GI] side effects) of single daily dose of GSK2981710 selected from Part 1. Part 2 of the study will include the Screening period, two Baseline assessments (6-8 days before each Treatment period) and two 14-day treatment periods separated by a minimum 7-day washout period and follow-up visit of 3 to 5 days. Approximately 50 to 80 subjects will be randomized to either GSK2981710 or placebo. The PD assessments will be performed on 6 occasions for each subject: at 2 baselines (6 to 8 days before Day 1 of each treatment period), post-dose on the Day 1 of each treatment period to assess acute effects and on Day 15 of each treatment period (which is the day after the final dose) to assess chronic effects. A subject's total participation in Part 2 of the study will last approximately up to 12 weeks including screening.
- Conditions
- Alzheimer's Disease
- Being tested
- GSK2981710, Placebo
- Keywords
- Consumer Healthcare, Ketones, Medium Chain Triglycerides, Age related cognitive decline, GSK Nutrition
- Medical subject headings
- Alzheimer Disease, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2981710Drug
Will be available as 10 g medium-chain triglycerides (MCT) powder sachet that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast
PlaceboDrug
Will be available as matching powder that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast
| Study group | Role | What they receive |
|---|---|---|
| Part 1: GSK2981710 10 gram (g) | Experimental | Eight subjects will receive single dose of GSK2981710 in the form of 10 g medium-chain triglycerides (MCT) powder daily for 14 days. Receives: Drug: GSK2981710 |
| Part 1: GSK2981710 20 g | Experimental | Eight subjects will receive single dose of GSK2981710 in the form of 20 g MCT powder daily for 14 days. Receives: Drug: GSK2981710 |
| Part 1: GSK2981710 30 g | Experimental | Eight subjects will receive single dose of GSK2981710 in the form of 30 g MCT powder daily for 14 days. Receives: Drug: GSK2981710 |
| Part 1: GSK2981710 40 g | Experimental | Eight subjects will receive single dose of GSK2981710 in the form of 40 g MCT powder daily for 14 days. Receives: Drug: GSK2981710 |
| Part 1: Placebo | Placebo comparator | Eight subjects will receive single dose of matching placebo daily for 14 days. Receives: Drug: Placebo |
| Part 2: GSK2981710 (dose to be decided from Part 1) | Experimental | The subjects will receive single dose of GSK2981710 in the form of MCT powder (dose to be decided from Part 1) daily for 14 days. Receives: Drug: GSK2981710 |
| Part 2: Placebo | Placebo comparator | The subjects will receive single dose of matching placebo daily for 14 days.. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Plasma BHB elevation time course of GSK2981710
To select the dose of GSK2981710 that achieves the best PK profile, the duration of maximum elevation of beta-hydroxybutrate (BHB) will be measured.
Measured: Baseline (Day 0 pre dose) and Day 1 post dose (per 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5 and 8 hrs) of each of the 4 treatment periods.
Part 1: Area under the time concentration curve (AUC) of GSK2981710
To select the dose of GSK2981710 that achieves the best PK profile the AUC of GSK2981710 will be measured.
Measured: Baseline (Day 0 pre dose) and Day 1 post dose (per 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5 and 8 hrs) of each of the 4 treatment periods.
Part 1: Maximum concentration (Cmax) of GSK2981710
To select the dose of GSK2981710 that achieves the best PK profile the Cmax of GSK2981710 will be measured.
Measured: Baseline (Day 0 pre dose) and Day 1 post dose (per 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5 and 8 hrs) of each of the 4 treatment periods.
Part 2: Change from Baseline in performance on CANTAB Paired Associates Learning task
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used. This test assesses visual memory and new learning
Measured: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
Part 2: Change from Baseline in performance on CANTAB Verbal Recognition Memory task
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses the participant's ability to recall as many of the words as possible immediately following the presentation of list of words.
Measured: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
Part 2: Change from Baseline in performance on CANTAB Spatial Working Memory (SWM) task
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses the participant's ability to retain spatial information and to manipulate remembered items in working memory.
Measured: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
Part 2: Change from Baseline in performance on CANTAB Rapid Visual Processing task
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses continuous performance and visual sustained attention.
Measured: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
Part 2: Change from Baseline in performance on CANTAB Reaction Time task
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test measures of attention, and combines simple reaction time and choice reaction time elements
Measured: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
Part 2: Change from Baseline in performance on Source Memory Task
This test measures the participant's ability to recognize objects previously presented on a computer screen, and more importantly, to recall the spatial location of those objects.
Measured: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
Secondary outcomes (10)
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by number of subjects with adverse events (AE)s
Safety and tolerability parameters will include recording of AEs, in Part 1 and Part 2 of the study.
Measured: Part 1: 3 weeks; Part 2: 8 weeks
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by change from Baseline in ECG readings
Safety and tolerability parameter will include the electrocardiogram (ECG) readings at Baseline (Day 0) and at end of Part 1 and Part 2 of the study. ECG will be performed at follow-up only if clinically indicated or pre-dose values are out of range as reviewed by the Principal Investigator or designee.
Measured: Part 1: Baseline and 3 to 5 days post last dose in each of the 4 treatment periods.
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by change from Baseline in laboratory values
Safety and tolerability parameters will include laboratory (clinical chemistry, fasting blood glucose and hematological parameters) values at Baseline for Part 1 and Day 1 for Part 2 and at end of Part 1 and Part 2 of the study.
Measured: Part 1: Baseline and 3 to 5 days post last dose in each of the 4 treatment periods.
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by change from Baseline in vital signs
Vital signs measurement include systolic and diastolic blood pressure, pulse rate and weight at Baseline (Part 2: Day 1) and at end of Part 1 and Part 2 of the study.
Measured: Part 1: Baseline and 3 to 5 days post last dose in each of the 4 treatment periods.
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by Gastrointestinal (GI) Symptom and stool diary
The subject will assess the GI symptom by capturing the information regarding GI symptoms, stool consistency and frequency in a self administered stool dairy card.
Measured: Part 1: Day -7 until Day 49.
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by Liking Assessment
The subject used the liking assessment scale to assess the degree of liking for the GSK2981710.
Measured: Part 1: Day 1 post dose of each of the 4 treatment periods.
Part 2: Change from Baseline in P300 EEG measurement
The P300 (P3) is an electrophysiological index of neural processing that reflects a variety of cognitive processes elicited by a change in the sensory environment. Change from Baseline (Day 0) will be calculated as value at Day 1 and Day 15 minus the value at Day 0.
Measured: Baseline and Day 1 and Day 15 of each of the 2 treatment periods.
Part 2: Resting EEG measurement
In this study the cognitive function will be assessed by measuring both high and low frequencies related to synchronized neuronal brain oscillations using resting electroencephalography (EEG).
Measured: Baseline and Day 1 and Day 15 of each of the 2 treatment periods.
Part 2: EEG measurement during Source Memory Task
To measure the participant's ability to recognize objects previously presented on a computer screen, and more importantly, to recall the spatial location of those objects EEG will be used. The EEG is an electrophysiological measure of electrical neural activity.
Measured: Baseline and Day 1 and Day 15 of each of the 2 treatment periods.
Part 2: Correlation between systemic exposure of BHB and selected PD measurements
The correlation between systemic exposure (AUC, partial AUC) of BHB and selected PD measurements will be assessed.
Measured: Day 1 and Day 15 of each of the 2 treatment periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study start5 Nov 2012
- Primary completion3 Jul 2015
- Study completion3 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702480
- Sponsor's protocol ID
- 116713
- Status last verified
- May 2017
- First submitted
- 4 Oct 2012
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Medium-Chain Triglycerides on Cognitive Function in Older Subjects With Age-Related Cognitive Decline
- ClinicalTrials.gov ID
- NCT01702480
- Acronym / sponsor ID
- 116713
- Conditions
- Alzheimer's Disease
- Keywords
- Consumer Healthcare, Ketones, Medium Chain Triglycerides, Age related cognitive decline, GSK Nutrition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2012 (actual)
- Primary completion
- 3 Jul 2015 (actual)
- Study completion
- 3 Jul 2015 (actual)
- First posted
- 8 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK] Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study investigating the PK profile of four different doses of GSK2981710. Eight subjects will receive a single dose of GSK2981710 10 gram (g), 20 g, 30 g, 40 g or placebo in the morning and have PK assessments (every 0.5 hrs up to 8 hrs post-dose) throughout the day in each period. Each subject will complete a total of four dosing sessions and 4 days of PK assessments in 2 weeks. The Part 1 PK data will be used for dose selection and pharmacodynamic (PD) assessment period in Part 2. If the data from Part 1 is inconclusive, an additional 8 subjects may be recruited and Part 1 repeated (possibly dropping some doses) to increase confidence. A subject's total participation in Part 1 of the study will last a maximum of approximately 7 weeks including screening. Subjects who have completed Part 1 may be screened for eligibility and enrolled for Part 2.
Part 2 (PD Assessment) is a double blind randomized, placebo-controlled 2-period crossover design with 14-day treatment periods investigating the efficacy (cognitive performance) and tolerability (gastrointestinal [GI] side effects) of single daily dose of GSK2981710 selected from Part 1. Part 2 of the study will include the Screening period, two Baseline assessments (6-8 days before each Treatment period) and two 14-day treatment periods separated by a minimum 7-day washout period and follow-up visit of 3 to 5 days. Approximately 50 to 80 subjects will be randomized to either GSK2981710 or placebo. The PD assessments will be performed on 6 occasions for each subject: at 2 baselines (6 to 8 days before Day 1 of each treatment period), post-dose on the Day 1 of each treatment period to assess acute effects and on Day 15 of each treatment period (which is the day after the final dose) to assess chronic effects. A subject's total participation in Part 2 of the study will last approximately up to 12 weeks including screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1: GSK2981710 10 gram (g) | Experimental | Drug: GSK2981710Eight subjects will receive single dose of GSK2981710 in the form of 10 g medium-chain triglycerides (MCT) powder daily for 14 days. |
| Part 1: GSK2981710 20 g | Experimental | Drug: GSK2981710Eight subjects will receive single dose of GSK2981710 in the form of 20 g MCT powder daily for 14 days. |
| Part 1: GSK2981710 30 g | Experimental | Drug: GSK2981710Eight subjects will receive single dose of GSK2981710 in the form of 30 g MCT powder daily for 14 days. |
| Part 1: GSK2981710 40 g | Experimental | Drug: GSK2981710Eight subjects will receive single dose of GSK2981710 in the form of 40 g MCT powder daily for 14 days. |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboEight subjects will receive single dose of matching placebo daily for 14 days. |
| Part 2: GSK2981710 (dose to be decided from Part 1) | Experimental | Drug: GSK2981710The subjects will receive single dose of GSK2981710 in the form of MCT powder (dose to be decided from Part 1) daily for 14 days. |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboThe subjects will receive single dose of matching placebo daily for 14 days.. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female individuals between the ages of 55 years and 80 years inclusive.
- A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. Child-bearing potential and has a negative pregnancy test on each of the testing visits.
- Body weight >=50 kilogram (kg) in males and >=40 kg in females. Body mass index (BMI) in the range 18.0 to 29.9 kg/meter (m)^2.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Sufficiently fluent in English that they are able to understand written and spoken instructions in the opinion of the investigator.
Key exclusion criteria (18 listed)
- Previous or current medical condition, which as judged by the Investigator with consultation with the GSK Medical Monitor if required, may compromise subject safety or may interfere with the study procedures or the interpretation of data..
- Learning disability or learning disorder.
- Current history of Axis I psychiatric disorder as determined by MINI interview
- A drug dependence by the Diagnostic and Statistical Manual of Mental Disorders, Fourth (DSM-IV) criteria within the last 6 months as assessed by the Mini-international neuropsychiatric interview (MINI).
- A fall of at least 20 mm Hg systolic blood pressure within three minutes of standing upright at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK2981710Will be available as 10 g medium-chain triglycerides (MCT) powder sachet that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast | Drug | Part 1: GSK2981710 10 gram (g), Part 1: GSK2981710 20 g, Part 1: GSK2981710 30 g, Part 1: GSK2981710 40 g, Part 2: GSK2981710 (dose to be decided from Part 1) |
| PlaceboWill be available as matching powder that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast | Drug | Part 1: Placebo, Part 2: Placebo |
Primary outcome
Part 1: Plasma BHB elevation time course of GSK2981710
Time frame: Baseline (Day 0 pre dose) and Day 1 post dose (per 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5 and 8 hrs) of each of the 4 treatment periods.
To select the dose of GSK2981710 that achieves the best PK profile, the duration of maximum elevation of beta-hydroxybutrate (BHB) will be measured.
Part 1: Area under the time concentration curve (AUC) of GSK2981710
Time frame: Baseline (Day 0 pre dose) and Day 1 post dose (per 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5 and 8 hrs) of each of the 4 treatment periods.
To select the dose of GSK2981710 that achieves the best PK profile the AUC of GSK2981710 will be measured.
Part 1: Maximum concentration (Cmax) of GSK2981710
Time frame: Baseline (Day 0 pre dose) and Day 1 post dose (per 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5 and 8 hrs) of each of the 4 treatment periods.
To select the dose of GSK2981710 that achieves the best PK profile the Cmax of GSK2981710 will be measured.
Part 2: Change from Baseline in performance on CANTAB Paired Associates Learning task
Time frame: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used. This test assesses visual memory and new learning
Part 2: Change from Baseline in performance on CANTAB Verbal Recognition Memory task
Time frame: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses the participant's ability to recall as many of the words as possible immediately following the presentation of list of words.
Part 2: Change from Baseline in performance on CANTAB Spatial Working Memory (SWM) task
Time frame: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses the participant's ability to retain spatial information and to manipulate remembered items in working memory.
Part 2: Change from Baseline in performance on CANTAB Rapid Visual Processing task
Time frame: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test assesses continuous performance and visual sustained attention.
Part 2: Change from Baseline in performance on CANTAB Reaction Time task
Time frame: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
To measure acute (after single dose) and chronic (after two weeks daily dosing) effects of GSK2981710 on cognition and neural function CANTAB will be used. This test measures of attention, and combines simple reaction time and choice reaction time elements
Part 2: Change from Baseline in performance on Source Memory Task
Time frame: Baseline (Day 0) and Day 1 (post dose) and Day 15 (post dose) of both treatment periods.
This test measures the participant's ability to recognize objects previously presented on a computer screen, and more importantly, to recall the spatial location of those objects.
10 secondary outcomes
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by number of subjects with adverse events (AE)s
Time frame: Part 1: 3 weeks; Part 2: 8 weeks
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by change from Baseline in ECG readings
Time frame: Part 1: Baseline and 3 to 5 days post last dose in each of the 4 treatment periods.
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by change from Baseline in laboratory values
Time frame: Part 1: Baseline and 3 to 5 days post last dose in each of the 4 treatment periods.
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by change from Baseline in vital signs
Time frame: Part 1: Baseline and 3 to 5 days post last dose in each of the 4 treatment periods.
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by Gastrointestinal (GI) Symptom and stool diary
Time frame: Part 1: Day -7 until Day 49.
Part 1 and 2: Safety and tolerability of GSK2981710 as assessed by Liking Assessment
Time frame: Part 1: Day 1 post dose of each of the 4 treatment periods.
Part 2: Change from Baseline in P300 EEG measurement
Time frame: Baseline and Day 1 and Day 15 of each of the 2 treatment periods.
Part 2: Resting EEG measurement
Time frame: Baseline and Day 1 and Day 15 of each of the 2 treatment periods.
Part 2: EEG measurement during Source Memory Task
Time frame: Baseline and Day 1 and Day 15 of each of the 2 treatment periods.
Part 2: Correlation between systemic exposure of BHB and selected PD measurements
Time frame: Day 1 and Day 15 of each of the 2 treatment periods.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Results for study 116713 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK2981710 in people with Alzheimer's Disease, run by GlaxoSmithKline at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Plasma BHB elevation time course of GSK2981710 (time frame: Baseline (Day 0 pre dose) and Day 1 post dose (per 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6, 6.5, 7, 7.5 and 8 hrs) of each of the 4 treatment periods.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.